Inflammatory bowel disease (IBD), incorporating Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic relapsing-remitting inflammatory disorder of the gastrointestinal tract.1 There is currently no cure for IBD and available treatments (e.g. aminosalicylates, immunosuppressant, biologics) have variable degrees of efficacy and tolerance. As a consequence, there is a large …
Building awareness with National Diabetes Month and new T2DM treatment guidelines
Coinciding with National Diabetes Month is the recent publication, Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), which contains the most up-to-date, impactful set of new treatment guidelines for patients with …
Mining real-world data with cutting-edge analytical tools: helping to achieve patient recruitment targets
In 1848, the most famous Gold Rush in American history began at Sutter’s Mill near present-day Coloma, California, shaping the US economic map forever. In those days, there were no scientific tools to guide prospectors in their search. Sites of previous finds were the starting point for what became, for …
Drug discovery is not black and white—why should Your studies be?
Medical imaging is a powerful tool that allows for in vivo and ex vivo quantification of various endpoints which can aid in oncology research and drug discovery. With a myriad of imaging options, how do you know which method is the most appropriate for your needs? The purpose of this blog is to bring …
Progress in treating chronic Kidney Disease patients with Cardiovascular Disease: Kidney Health Initiative develops clinical research recommendations
Throughout the world, kidney disease is far more common than most people realize. It’s not a stretch to call it a “hidden epidemic,” as the number of people living with kidney disease (850 million) is roughly twice that of those living with diabetes.(1) The health issue presented by chronic kidney disease (CKD) …
The impact and use of social media in pharmacovigilance
Pharmacovigilance (PV) has evolved and grown more complex over the past 5 to 10 years due to increasing data volumes, evolving regulations, influence of emerging markets and the emerging social media and innovative technological advances. Digital media is now used by biopharmaceutical companies for communication with patients to create awareness about diseases and treatments, clinical …
Designing a comprehensive self-administration drug abuse liability study | Part II
Series Introduction Regulatory agencies require that any drug (parent or major metabolite) that penetrates the brain and has CNS activity, regardless of its therapeutic indication, be assessed for that drug’s abuse potential. In this series on Assessing Potential Drug Abuse, we are sharing how the team designs and setup accurate and valid nonclinical …
evaluation of immune response following treatment with Anti-CTLA-4 antibody, radiation therapy, or combination in murine model of breast cancer
Breast cancers are considered poorly immunogenic tumors, however, several approaches utilizing immunotherapies are being undertaken in the clinic to evaluate their potential for improving outcomes. Radiation therapy (RT) is a highly utilized clinical treatment modality in breast cancer. Radiation is known to modify the tumor microenvironment, induce cytokines and chemokines, …
Emerging immuno-oncology therapies: life after checkpoint inhibitors
The clinical approval of biological therapeutics inhibiting CTLA-4 (ipilimumab), PD-1 (nivolumab, pembrolizumab) and PD-L1 (atezolizumab, avelumab, durvalumab) has ushered in a revolution in the field of cancer immunotherapy. Thus far, the approvals have occurred in a small number of cancer histotypes including melanoma, non-small cell lung cancer and urothelial cancers, …
Flow cytometry based functional assays essential for characterizing biological significance
The efficacy of immune-modulating anti-cancer therapeutic antibodies that have been FDA-approved in recent years, such as anti-CTLA-4 and anti-PD-1, has driven growing interest in methods that provide a mechanistic understanding of drug function. Development of new mono and combination therapies with immune-modulatory effects requires more powerful immunophenotyping techniques capable of …